Checking in on (RBQM) Risk Based Quality Management One Year After ICH E6(R3)
Risk Based Quality Management One Year After ICH E6(R3) The industry is navigating a complex transition, balancing the adoption of innovative technology, maintaining study timelines, ensuring patient safety, and safeguarding data integrity. RBQM is a vital in helping with the adoption of these new technologies. The risk-based approach is foundational to creating a data-driven culture […]
Key Regulatory issues to monitor for clinical trials in 2024 and beyond
The regulatory landscape surrounding clinical trial data is undergoing continual expansion and complexity, necessitating vigilant attention from clinical researchers as they navigate evolving regulations. Influential policy recommendations and guidance documents are starting to surface against this dynamic backdrop in important countries like the US, the EU, Canada, and beyond. These projects have the potential to […]
Clinical Trials 101: Your Guide to Understanding How It Works
In the world of medical research, clinical trials are the forefront of advancement of research. They bridge the gap between laboratory breakthroughs and real-world treatments, ensuring that new drugs, therapies, or devices are both safe and effective. This comprehensive guide aims to shed light on these vital components of healthcare advancement. What are Clinical Trials? […]
On Demand Webinar – Decentralized Clinical Trials and Digital Health Navigating the Opportunities and Challenges
Overview: As the healthcare industry pushes towards modernizing clinical trials, recent draft guidance from the FDA, ICH, and others aims to guide the industry in adopting decentralized clinical trials (DCT) and digital health technologies for remote data acquisition. These new approaches present a significant opportunity to transform the way clinical trials are conducted, with potential […]
White Paper – FDA Draft Guidance Summary Decentralized Clinical Trials for Drugs, Biological Products, and Devices
White Paper from Astrix Clinical Services The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of […]